Maven Profcon Services LLP β Global Medical Device Regulatory Consultants | CE Marking | US FDA | ISO 13485 | MDSAP | UKCA
Maven Profcon Services LLP helps medical device and IVD manufacturers navigate global regulatory frameworks and achieve international compliance.
Our expertise includes CE Marking (EU MDR & IVDR), US FDA 510(k), ISO 13485, MDSAP, and Indian MDR certifications.
We support manufacturers with:
π Document Reviews
π Gap Assessments
π Regulatory Trainings & Internal Audits
π§ͺ Mock Audits & Non-Conformity Closures
π Conformity Assessments
π§ Management Review Support
Backed by a team of engineers, regulatory experts, trainers, and lead auditors, Maven delivers practical and scalable regulatory solutions for both startups and established manufacturers.
π Supporting medical device companies worldwide.
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